Implementing iron management clinical practice guidelines in patients with chronic kidney disease having dialysis

Studies examining the link between research evidence and clinical practice have consistently shown gaps between the evidence and current practice. Some studies in the United States suggest that 30%–40% of patients do not receive evidence-based care, while in 20% of patients care may be not needed or potentially harmful.1 However, relatively little information exists about how to apply evidence in clinical practice, and data on the effect of evidence-based guidelines on knowledge uptake, process of care or patient outcomes is limited.

In Australia and New Zealand, national guidelines for treating patients with chronic kidney disease — the Caring for Australasians with renal impairment (CARI) guidelines2 — were published and disseminated to nephrologists in March 2000, with details and updates on the CARI website (http://www.cari.org.au). They provide nephrologists, renal nurses and other health carers with an evidence base for patient management and improving outcomes.

The focus of one of the CARI guidelines2 is anaemia, a common complication of chronic kidney disease. Management of iron levels in patients with chronic kidney disease involves both excluding iron deficiency in uraemic–anaemic patients, and providing adequate iron stores to allow patients to efficiently maintain target haemoglobin concentrations, especially with the concomitant use of supplementary erythropoietin proteins (epoetin). Failure to achieve adequate iron stores and availability is the major cause of epoetin resistance, which may result in increased costs to correct the anaemia.3 In observational studies of haemodialysis patients, it has been shown that the relative risk of death and hospitalisation increases significantly with haemoglobin levels below the target.4

In an effort to understand the impact of guidelines, our study was designed to evaluate the outcomes of a standard implementation strategy (passive dissemination of guidelines in hardcopy form and on the Internet) of the CARI guidelines using an example — iron management of dialysis patients in Australia. In assessing this strategy, we sought to identify barriers to guideline implementation5-7 using a “process of care” approach, with a view to developing strategies to increase uptake of evidence into practice. We hope that lessons learned from this process can be applied in other clinical environments.

There were 1763 patients in the dataset from the six units (Box 1). Statistically significant differences were found between median values for haemoglobin (P < 0.001), ferritin (P < 0.001) and TSAT levels (P < 0.001). Among the units, patients’ median haemoglobin levels ranged from 112 g/L to 121 g/L, median ferritin levels from 163 μg/L to 501 μg/L, and median TSAT percentages varied from 23% to 29%.

Box 2 shows the proportion of patients who were within or outside CARI target iron parameters for each unit. The proportions were significantly different across the units. The greatest difference was in ferritin levels in Unit 3 compared with Unit 5, with 26% versus 68% of patients in the target range, respectively.

Box 3 shows the process pathway for iron management across the units. Each unit varied each of the steps depending on local protocols. Practices differed widely from the CARI guideline and between the units. Most units agreed with the CARI guideline on the lower margin of the range for iron stores, but there was a tendency for all units in their local adaptation of the guideline to adopt a lower level for the upper limit for iron stores. Units also varied widely in the frequency with which iron studies were undertaken, as well as whether oral or intravenous iron therapy was administered and what dosages were used.

The process for iron management was different for each unit. All units had a written iron protocol, but not all units complied with their protocol. Units 1, 5 and 6 had a written, agreed and implemented protocol. Units 1 and 5 had a standing order for iron that allowed nursing staff to administer iron within this specified protocol. Units 1, 5 and 6 had a decision aid for administering iron. Many variables affected the iron management process. A summary of each unit’s iron management process is given in Box 4.

The possible barriers to more successful implementation of the guideline, which were identified from the results of the review of the six units, are listed in Box 5.

Each staff member interviewed was aware of the CARI guidelines and the iron guideline disseminated in March 2000. Not all were aware that the website carries updates.

Passive dissemination of the CARI guidelines in March 2000 resulted in awareness of the iron guideline, but we found significant variation in implementation of the guideline across the six dialysis units examined. All units had an iron management process in place; however, the variability of the levels achieved for the iron indices is a measure of the effectiveness of the process. An effective process seems to depend on the strength of a unit’s local protocol and the staff available to drive the protocol processes.

Every step in the iron management clinical process pathway (Box 3) contains factors influencing iron management. Identifying strengths and weaknesses in this process for individual units will aid implementation. As our study is primarily a qualitative study, drawing statistical inferences is difficult. However, there appears to be a link between achieving higher ferritin concentrations and autonomy given to nursing staff to manage patients’ iron levels under an agreed protocol. Other factors that appear to influence guideline adherence and patient outcomes are:

• agreement between nursing staff and nephrologists on a protocol for the unit;

• using an effective decision aid (Box 6);

• the number of nephrologists practising in a particular unit (negative effect with increasing numbers);

• the degree of physician reliance on a protocol being actively implemented; and

• the iron management protocol being “proactive” rather than “reactive”. Evidence suggests that a proactive or maintenance-dosing iron therapy regimen is superior to a reactive regimen (ie, only prescribing iron therapy when iron indices are outside the defined ranges).3,9,10

Some dialysis facilities had lower target haemoglobin concentrations and lower achieved levels, possibly due to concerns about increased thrombotic risk and mortality rates. These concerns were raised by the publication of a randomised controlled trial linking an increase in mortality to high haemoglobin concentrations in haemodialysis patients with symptomatic heart failure.11 Another barrier to aggressive iron administration is a reluctance on the part of nephrologists to allow ferritin levels to become “too high”. Although all agreed that the lower limit for ferritin should be > 300 μg/L, some believed that the CARI guideline upper limit of 800 μg/L was too high and exposed patients to the risk of iron toxicity (ie, increased risk of infection, oxidative stress,12 and impaired neutrophil function).13 Some dialysis units subsequently adopted a revised local protocol, lowering target ferritin concentrations to differing extents. This change in practice is reflected in the new evidence-based CARI guideline published in April 2006 in which the upper limit for ferritin has been reduced to 500 μg/L.14

A potential limitation of our study is the small number of dialysis units surveyed. However, the patients in the six units involved were a 23% sample of the Australian dialysis population (March 2004), and care was taken to ensure they were generally representative of the population of patients with chronic kidney disease having dialysis. We included a range of units with different practices and iron indices, and our data show substantial variability, which we sought to explain.

The sample had a lower proportion of Aboriginal and Torres Strait Islander patients compared with the overall Australian dialysis population. Indigenous patients have been reported to have lower ferritin and TSAT values than non-Indigenous patients, and may require different iron management processes.15 Further research into the needs of Indigenous patients having dialysis is required to determine their particular requirements and the applicability of the CARI guideline to Indigenous patients.

There is a growing body of research on how evidence is taken up into clinical practice. The most common strategies in use — continuing medical education and passive dissemination of guidelines — have consistently been shown to have very little impact on practice patterns or improving patient outcomes.7,16-19 For successful implementation of guidelines, it is necessary to devise a strategy or plan for the project.6-8 The first task is to understand the local setting for implementation and the target group,20 as well as the current process or clinical pathway that needs to be altered (Box 3). Understanding each step in the clinical pathway and how individual units move through these stages will reveal the barriers to change for those units,5-7,20 and a multifaceted implementation plan can be devised to overcome these barriers.16,19-21

In our study, identification of barriers was made at seven different levels of the organisation, using the National Institute for Clinical Studies barrier tool.22 Box 5 shows the many possible barriers at all units, involving nephrologists, renal nurses, patients, and issues at a unit level, management level or infrastructure level, as well as the guideline itself. Individual units wanting to implement the iron guideline can identify which barriers may be applicable to them and devise strategies to overcome these. Once these barriers have been overcome, regular audits are needed to ensure that the performance indicators have improved (ie, the proportion of patients achieving targets has increased). This completes the quality cycle, ensuring ongoing delivery of optimal evidence-based care.

Research into effective methods for implementing clinical practice guidelines lags behind the research methods involved in producing guidelines. Our study highlights the possible barriers to implementing the CARI guideline for iron. To truly gain an understanding of which guideline implementation methods are most successful, controlled-intervention observational studies and completion of the quality cycle, with critical review of the achievement of targets, should be undertaken in renal medicine.

Passive dissemination of the CARI iron guideline (our example) raised awareness of the guideline, but improving iron management and patient outcomes will take commitment to change within the renal care team, an agreed iron protocol with a decision support aid, a working process for iron management, and skills improvement for renal nursing staff. Factors affecting iron management and barriers to change are numerous. For successful guideline implementation, a strategy to overcome these barriers in individual units should be planned and executed.

This example can be adapted to other clinical settings across a range of medical disciplines. Successful implementation of clinical practice guidelines is not achieved by forcing physicians to obey “rules”, but rather by creating an environment in which they are given the skills, knowledge, attitudes and support systems to help them provide their patients with the best possible care, based on the best possible evidence.

2 Haemoglobin and iron indices ranges (all units) by dialysis unit (1 to 6) for patients taking epoetin

3 Clinical pathway for iron management in patients with renal impairment

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CARI = Caring for Australasians with renal impairment.